Cleared Traditional

K983548 - FERRITIN CALIBRATOR

K983548 is the FDA 510(k) clearance for FERRITIN CALIBRATOR by Dade Behring, Inc.. It is a Class 2 Immunology device (product code JIT) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K983548 · Dade Behring, Inc. · Immunology device
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Oct 1998
Decision
18d
Days
Class 2
Risk

K983548 is an FDA 510(k) clearance for the FERRITIN CALIBRATOR. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on October 27, 1998 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1150 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dade Behring, Inc. devices

Submission Details

510(k) Number K983548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1998
Decision Date October 27, 1998
Days to Decision 18 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 104d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIT Calibrator, Secondary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - JIT Calibrator, Secondary

All 145
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K983548.
DIMENSION AHDL CALIBRATOR
K983850 · Dade Behring, Inc. · Nov 1998
DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR
K983693 · Dade Behring, Inc. · Nov 1998
STRATUS CS TROPONIN I CALIBRATOR
K983722 · Dade Behring, Inc. · Nov 1998
PREALBUMIN CALIBRATOR
K982292 · Dade Behring, Inc. · Aug 1998
STRATUS CS CKMB CALPAK
K981097 · Dade Behring, Inc. · Apr 1998
STRATUS CS TROP CALPAK
K981100 · Dade Behring, Inc. · Apr 1998